The Stryker Ureteral Illuminator System III is an ureteral transillumination device with a reusable illumination source and a fiberoptic light ureteral catheter kit which is provided sterile for single use disposable application. The Stryker Ureteral Illuminator System III is intended to transilluminate the ureter during laparoscopic and open surgical procedures. Transillumination is intended to help the ureter(s) during open or laparoscopic surgical procedures of the lower abdomen or pelvic areas. The Stryker Ureteral Illuminator System III illumination source will comply with UL 544 Standard for Medical and Dental Equipment and 21 CFR 1040.10 Performance Standards for Lasers. The Stryker Ureteral Illuminator System III fiberoptic light ureteral catheter kit will be constructed of materials which are tested for biocompatibility per ISO 10993 and are safe, effective, and durable for their intended purposes. The Stryker Ureteral Illuminator System III EtO sterilization processes are validated per AAMI/ANSI/ISO 11135, to a SAL of 10-6.

AI/ML Overview

The provided text does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding AI integration for the Stryker Ureteral Illuminator System III. The submission is a 510(k) for a medical device that predates the widespread use of sophisticated AI in medical devices, and focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot provide answers to the requested points, as the information is not present in the given document. The document primarily discusses:

Device Name and Classification: Stryker Ureteral Illuminator System III, classified under 21 CFR 876.4020 for fiberoptic light ureteral catheters.
Intended Use: To transilluminate the ureter during laparoscopic and open surgical procedures to help locate the ureters.
Safety and Effectiveness: Stated to be equivalent to existing marketed devices (specifically Gabriel Ureteral Illuminator System II - K945088).
Compliance: Mentions compliance with UL 544, 21 CFR 1040.10, ISO 10993 for biocompatibility, and AAMI/ANSI/ISO 11135 for sterilization validation.
FDA Determination: A letter from the FDA stating the device is substantially equivalent to predicate devices marketed before May 28, 1976.

The traditional 510(k) process for a device like this relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a detailed performance study against specific acceptance criteria in the manner you've described for AI/algorithm-driven devices. Performance is often inferred from the predicate device's established safety and effectiveness.

Summary

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APPENDIX F

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2590 Walsh Ave. Santa Clara, CA 95051 SUMMARY SAFETY AND EFFICACY

Device Name

Current Classification Name(s):

Fiberoptic light ureteral catheters under 21 CFR 876.4020 by the Gastroenterology-Urology Devices Panel.

Common and Usual Name:	Stryker Ureteral Kit II or U-kit II
Proprietary Name:	Stryker Ureteral Illuminator System II
Device Sponsor	Stryker Endoscopy2590 Walsh Ave.Santa Clara, CA 95051

This summary of 510(k) safety and effectiveness is being submitted in accordance with requirements of SMDA 1990.

The Stryker Ureteral Illuminator System III fiberoptic light ureteral catheter kit will be constructed of materials which are tested for biocompatibility per ISO 10993 and are safe, effective, and durable for their intended purposes. The Stryker Ureteral Illuminator System III EtO sterilization processes are validated per AAMI/ANSI/ISO 11135, to a SAL of 10-6.

The Stryker Ureteral Illuminator System III is equivalent in safety and effectiveness to a variety of devices currently marketed (Gabriel Ureteral IIIuminator System II - K945088) which are used in the applications noted above for general transillumination purposes.

This device does not raise new issues when compared to its predicate devices or uses. Therefore, it is considered substantially equivalent to those devices.

Sean Cahill Design Engineer

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Image /page/1/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 1998

Mr. Sean Cahill Design Engineer Stryker Endoscopy 2590 Walsh Avenue Santa Clara, CA 95051 Re: K982542

Stryker Ureteral Illuminator System III Dated: July 17, 1998 Received: July 21, 1998 Regulatory Class: II 21 CFR 876.4020/Procode: 78 FCS

Dear Mr. Cahill:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrb/dsmaldsmamain.html".

Sincerely yours

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of

510(k) Number (if known):

Device Name:_ Stryker Ureteral Illuminator System III

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Prescription Use
(Per 21 CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ermid C. Siggens

Over-The-Counter Use

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Regulation Number and Section

§ 876.4020 Fiberoptic light ureteral catheter.

(a)
Identification. A fiberoptic light ureteral catheter is a device that consists of a fiberoptic bundle that emits light throughout its length and is shaped so that it can be inserted into the ureter to enable the path of the ureter to be seen during lower abdominal or pelvic surgery.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.